Interpretive multichannel electrocardiograph

Intended purpose

Impala is intended to record, store, and transfer a 12-lead resting electrocardiogram (ECG). Impala acquires four standard diagnostic-bandwidth leads (Leads I, II, V2, V4, or Leads I, II, V1, V4). The device derives four standard diagnostic- bandwidth, Lead-III and unipolar limb leads aVR, aVF and aVL. The device also synthesizes Leads V1 or V2, V3, V5, V6, which are similar to but not identical to the same leads of a standard diagnostic 12-lead. The 4 synthesized chest leads are not intended for diagnostic use and may fail to show important findings limited to those leads. This device is not a substitute for a diagnostic 12-lead ECG and is contraindicated for use in ruling out any condition (including but not limited to certain ischemia/infarcts, Brugada syndrome) for which the diagnosis may be solely dependent on the synthesized leads. The device also provides ECG measurements and ECG analysis (rhythm and morphological interpretation) using the acquired leads. The automated ECG analysis results are provisional and should not be used for clinical action if it has not been reviewed by a qualified physician capable of independently interpreting the ECG signal in the context of the patient's condition. The automated analysis may then be confirmed, edited, or deleted by a qualified physician. ECG analysis should be used only as an adjunct to clinical history, symptoms, and the results of other non-invasive and/or invasive tests. Impala is intended for use with patients aged 18 years and older. Impala is intended for use by healthcare professionals, or trained personnel in healthcare facilities (e.g. the doctor’s office or hospital) and in acute settings.